UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037530 |
|---|---|
| Receipt number | R000042785 |
| Scientific Title | A clinical study for evaluating the effects of lactic acid bacterium containing foods on improvement of bowel movement and immune function. : randomized, double-blind, placebo-controlled parallel trial. |
| Date of disclosure of the study information | 2019/07/30 |
| Last modified on | 2020/01/28 09:26:37 |
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Basic information
Public title
A clinical study for evaluating the effects of lactic acid bacterium containing foods on improvement of bowel movement and immune function. : randomized, double-blind, placebo-controlled parallel trial.
Acronym
A clinical study for evaluating the effects of lactic acid bacterium containing foods on improvement of bowel movement and immune function.
Scientific Title
A clinical study for evaluating the effects of lactic acid bacterium containing foods on improvement of bowel movement and immune function. : randomized, double-blind, placebo-controlled parallel trial.
Scientific Title:Acronym
A clinical study for evaluating the effects of lactic acid bacterium containing foods on improvement of bowel movement and immune function.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of 4-week intake of lactic acid bacteria containing foods on improvement of bowel movement and immune function in healthy volunteers with a tendency to be constipated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation frequency, feeling after defecation, ease of defecation, amount, smell and color of feces, fecal condition (Measure at a daily basis for 1 week during the pre-treatment period, and in the week right before the 2nd, 4th and 6th week when the treatment started)
Activity of NK cell and concentration of IgA in blood
(Measure at before ingestion and after 4-week intake)
Key secondary outcomes
Adverse event(Inquiry consultation)
Blood lipid maker
(Measure at before ingestion and after 4-week intake)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Pre-treatment observation period(1 week), treatment observation period, subject take the test food(4 weeks), post-treatment observation period(2 weeks)
Interventions/Control_2
Pre-treatment observation period(1 week), treatment observation period, subject take the placebo food(4 weeks), post-treatment observation period(2 weeks)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Males and females, aged 20 - 65 years old with constipation tendency with defecation frequency 5 times or less per week.
2) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
1) Subjects who have medical history of malignant tumor, heart failure or myocardial infarction.
2) Subject receiving treatment for gastrointestinal diseases and constipation disease.
3) Currently undergoing treatment for or having a medical history with any of the following chronic diseases: atrial fibrillation, cardiac arrhythmia, liver failure, kidney failure, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4) Subjects who frequently take medicines for intestinal disorder or laxatives
5) Subjects who frequently take medicines (including herbal medicines)
6) Subjects who are allergic to medicines and/or the test food related products.
7) Subjects with irregular life rhythms such as shift workers, irregular eating habits.
8) Subjects who are pregnant, breast-feeding, or planning to get pregnant.
9) Subjects who have been enrolled in other clinical trials.
10) Subjects who are considered as ineligible to participate in the study by the physician.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Yamatsu |
Organization
Pharma Foods International Co., Ltd.
Division name
Research and Development department
Zip code
615-8245
Address
1-49, Goryo-Ohara, Nishikyo-ku, Kyoto
TEL
0753948605
a-yamatsu@pharmafoods.co.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Ishida |
Organization
Pharma Foods International Co., Ltd.
Division name
Research and Development department
Zip code
615-8245
Address
1-49, Goryo-Ohara, Nishikyo-ku, Kyoto
TEL
0753948605
Homepage URL
a-ishida@pharmafoods.co.jp
Sponsor or person
Institute
Other
Pharma Foods International Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Self-funding
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Pharma Foods International Research Ethics Committee
Address
1-49, Goryo-Ohara, Nishikyo-ku, Kyoto
Tel
0753948600
m-aosasa@pharmafoods.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
24
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 04 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 29 | Day |
Last modified on
| 2020 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042785
